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Early Digi-physical Support During Breastfeeding Initiation - a Single-blind Randomized Controlled Trial

Primary Purpose

Breastfeeding, Self Efficacy, Breastfeeding Duration

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Digi-physical breastfeeding support
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding focused on measuring Breastfeeding, Depression, Primary Health Care, Digi-physical support, RCT

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being pregnant or partner of a person who is pregnant in pregnancy week 20-32 All parents with language skills enabling them to fill out questionnaires, participate in interviews and read information. Being resident in Stockholm Region Exclusion Criteria: Parents without adequate Swedish language skills Parents resident outside the Stockholm Region

Sites / Locations

  • Region Stockholm/Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Interventions: At discharge from the maternity ward: contact with lactation consultant (breastfeeding support and care) via the support hotline with chat as soon as questions or problems arise. The hotline will be available during the whole project period. After discharge from the maternity ward: paediatric nurse from Child Health Care Unit (CHC) will contact families and make a home visit (physical or digital), giving extended lactation advice and support. Additional home visits if needed. After discharge until one year after childbirth: possibility to get contact with specialized lactation consultant/nurse at lactation counseling units if needed. The intervention group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.

The control group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.

Outcomes

Primary Outcome Measures

Exclusive breastfeeding at 6 months and duration of breastfeeding
Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group

Secondary Outcome Measures

Prevalence of depression symptoms
Compare prevalence of depression symptoms between intervention and control group 6-8 weeks after births and 6 plus 12 months after birth.

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT06044636
Brief Title
Early Digi-physical Support During Breastfeeding Initiation - a Single-blind Randomized Controlled Trial
Official Title
Early Digi-physical Support During Breastfeeding Initiation Linked to Continued Support at Breastfeeding Clinic - a Single-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this Randomized Controlled Trial is to develop and evaluate a digi-physical intervention within primary health care lactation counselling and breastfeeding support to promote exclusive breastfeeding rates during the first 6 months after birth and to prevent depressive symptoms. The project addresses parents during pregnancy week 20 and 32 and will continue during the infant's first year of life. All participants will get access to an evidence-based information package (theory and practical advises) during pregnancy. Study aim is to develop and evaluate digital evidence-based information materials and continuous support for both parents in order to increase prevalence of exclusive breastfeeding and duration as well as decreasing the risks of symptoms of post-partum depression.
Detailed Description
The project design is a single-blind randomized controlled trial. The intervention group will receive: Digital support by chat with a lactation consultant for immediate breastfeeding support two-three weeks after delivery Extended home visits by pediatric nurses providing extra knowledge and support about lactation Extra support by health care providers educated in lactation counseling when needed. More specific purposes are: Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group. (Primary outcome) Compare prevalence of depression symptoms between the intervention and control group. (Secondary outcome) Strengthening parents' self-efficacy in breastfeeding their child.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Self Efficacy, Breastfeeding Duration, Depression
Keywords
Breastfeeding, Depression, Primary Health Care, Digi-physical support, RCT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Interventions: At discharge from the maternity ward: contact with lactation consultant (breastfeeding support and care) via the support hotline with chat as soon as questions or problems arise. The hotline will be available during the whole project period. After discharge from the maternity ward: paediatric nurse from Child Health Care Unit (CHC) will contact families and make a home visit (physical or digital), giving extended lactation advice and support. Additional home visits if needed. After discharge until one year after childbirth: possibility to get contact with specialized lactation consultant/nurse at lactation counseling units if needed. The intervention group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.
Intervention Type
Other
Intervention Name(s)
Digi-physical breastfeeding support
Other Intervention Name(s)
breastfeeding councelling
Intervention Description
Breastfeeding support after birth is provided via chat Extended home visits by a pediatric nurse after discharge from the maternity ward Extra support from a lactation counselor when needed after discharge until one year after childbirth
Primary Outcome Measure Information:
Title
Exclusive breastfeeding at 6 months and duration of breastfeeding
Description
Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group
Time Frame
From birth until child is one year old
Secondary Outcome Measure Information:
Title
Prevalence of depression symptoms
Description
Compare prevalence of depression symptoms between intervention and control group 6-8 weeks after births and 6 plus 12 months after birth.
Time Frame
From birth until child is one year old
Other Pre-specified Outcome Measures:
Title
Parents' self-efficacy breastfeeding their child
Description
Compare how parents' self-efficacy breastfeeding their child is improved
Time Frame
From birth until child is one year old

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being pregnant or partner of a person who is pregnant in pregnancy week 20-32 All parents with language skills enabling them to fill out questionnaires, participate in interviews and read information. Being resident in Stockholm Region Exclusion Criteria: Parents without adequate Swedish language skills Parents resident outside the Stockholm Region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Taloyan, Assoc.Prof.
Phone
0046737464551
Email
marina.taloyan@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Taloyan, Assoc.Prof.
Organizational Affiliation
Region Stockholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Stockholm/Karolinska Institutet
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Taloyan, Assoc. Prof.
Phone
0046737464551
Email
marina.taloyan@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Digi-physical Support During Breastfeeding Initiation - a Single-blind Randomized Controlled Trial

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